A Multicenter, Double-blind, Randomized, Parallel-group, Active Control Study to Compare the Efficacy, Safety, and Immunogenicity of AVT02 Versus Humira® in Patients with Moderate-to-Severe Chronic Plaque Psoriasis (ALVOPAD PS)

INTERVENTION: Product Name: adalimumab Product Code: AVT02 Pharmaceutical Form: Solution for injection in pre‐filled syringe INN or Proposed INN: ADALIMUMAB CAS Number: 331731‐18‐1 Current Sponsor code: AVT02 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40‐ Trade Name: Humira Product Name: Humira Pharmaceutical Form: Solution for injection in pre‐filled syringe INN or Proposed INN: ADALIMUMAB CAS Number: 331731‐18‐1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40‐ CONDITION: Chronic Plaque Psoriasis ; MedDRA version: 20.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 ‐ Skin and subcutaneous tissue disorders Therapeutic area: Diseases [C] ‐ Immune System Diseases [C20] PRIMARY OUTCOME: ; Secondary Objective: Secondary Objectives:; • To compare the efficacy of AVT02 and EU‐approved Humira in patients with moderate‐to‐severe chronic plaque psoriasis at Visits 8, 12, 16, 24, 32, 42, and 50; • To compare steady‐state pharmacokinetics of AVT02 and EU approved Humira; • To compare the safety, tolerability, and immunogenicity of AVT02 and EU‐approved Humira at Weeks 16, 24, 32, 42, and 50; ; Exploratory Objectives:; • To compare the efficacy of AVT02 and EU‐approved Humira in patients with psoriatic arthritis (PsA) at Week 12; • Change from Baseline (BL) in Routine Assessment of Patient Index Data 3 (RAPID3) at Week 12 (only for PsA); • To assess ex‐vivo immunogenicity by T‐cell proliferation and cytokine production in a subset of patients at Weeks 1, 8, and 16; ; Main Objective: •To assess the equivalence by Psoriasis Area and Severity Index (PASI) of AVT02 to EU‐approved Humira with regards to efficacy at Week 16 in patients with moderate‐to‐severe chronic plaque psoriasis Primary end point(s): •Percent improvement in Psoriasis Area and Severity Index (PASI) from BL to Week 16 Timepoint(s) of evaluation of this end point: 16 weeks SECONDARY OUTCOME: ; Secondary end point(s): •Percent improvement in PASI from BL to Week 8, 12, 24, 32, 42, and 50; •PASI 50, PASI 75, PASI 90, and PASI 100 response rate at Weeks 16, 24, and 50; •Number and percentage of patients achieving sPGA responses of clear (0) or almost clear (1) at Weeks 16, 24, and 50; •Change from BL in quality of life as measured by Dermatology Life Quality Index (DLQI) scores at Weeks 16, 24, and 50; Timepoint(s) of evaluation of this end point: 50 weeks INCLUSION CRITERIA: 1.Patient has signed the Informed Consent Form (ICF) and is able to understand and adhere to the visit schedule and study requirements. 2.Patient is male or female, 18 to 75 years of age, inclusive, at time of Screening. 3.Patient with moderate‐to‐severe chronic plaque psoriasis who has involved body surface area (BSA) = 10% (Palm Method), = 12 on the PASI, and static Physicians Global Assessments (sPGA) = 3 (moderate) at Screening and at BL. 4.Patient has had stable psoriatic disease for at least 2 months (ie, without significant changes as defined by the Investigator or designee). 5.Patient is a candidate for systemic therapy and the patient has a previous failure, inadequate response, intolerance, or contraindication to at least 1 systemic antipsoriatic therapy including, but not limited to, methotrexate, cyclosporine, psoralen plus ultraviolet light A (PUVA), and ultr